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This invention relates to a medical preparation for treating arthrosis, arthritis and other rheumatic joint diseases comprising a suspension of coated magnetizable particles that generate heat in the diseased tissue by applying an alternating electromagnetic field.
Chronically painful defects of the skeletal and locomotor system resulting in permanent restricted movement such as arthritis, arthrosis and rheumatic diseases are first of all treatedxe2x80x94in addition to physical forms of therapyxe2x80x94by a systemic pharmacotherapy using analgesics and non-steroidal antiphlogistics and cortisone which does not combat the causes of the disease and has undesirable side-effects.
Another known therapy called radiosynoviorthesis uses stabilized isotopes with a range of only a few millimeters to combat the pathogenic growth of the synovium. These are injected into the diseased joint to damage the synovial cells by radiation and thus control the inflammatory process.
However, the efficacy of radiosynoviorthesis requires the phagocytic activity of macrophages that are present in increased numbers in the synovial fluid due to the inflammation but tend to decline in numbers the older the patients are, thus limiting the successful application of radiosynoviorthesis.
In accordance with U.S. Pat. No. 4,758,429, a patient would be given an intravenous injection of colloidal suspensions consisting of ferromagnetic, paramagnetic, or diamagnetic particles of either Fe2O3 or FeOOH that are less than 1 micron in size and have coatings comprising dextran, metalloporphyrins as well as inorganic and organic metal compounds as substituents in the iron core. Application of an alternating electromagnetic field is to provide energy to the diseased area, however it remains unclear how the coated iron oxide particles are supposed to get to the diseased site. Colloidal suspensions on the basis of iron oxide particles coated as described are incapable of effectively containing the inflammatory processes of arthritis, arthrosis, and other rheumatic diseases. Nanoscalar particles with a ferrimagnetic, ferromagnetic, or superparamagnetic core containing iron oxide and comprising at least two shells that encompass said core were disclosed in DE 197 26 282 as part of a tumor therapy by hyperthermia. In this invention, the shell adjacent to said core comprises numerous positively charged functional groups that facilitate easy absorption of the coated iron core into the tumor cell, and the tumor tissue decomposes said shell slowly enough for said core to adhere to the cell""s surface and subsequently be absorbed by the cell. The outer shells are made of species that protect the positively charged groups of the inner shell underneath to make said nanoscalar particles appear neutral or negatively charged at their outer side. The particles form a magnetic fluid and are injected at various spots into the tumor tissue and, due to their design, are thus well distributed within the tumor tissue and well incorporated into the interior of the tumor cells. Successful treatment by hyperthermia is enabled after applying an alternating electromagnetic field and the temperatures it produces due to the even distribution of the nanoscalar particles.
These known nanoscalar particles are not designed for treating joint diseases and cannot guarantee success in their present form. It is therefore the problem of this invention to provide a means for local and systemic treatment of arthrosis, arthritis and other rheumatic joint diseases that guarantees effective pain killing and containment of the inflammatory process in the diseased joints based on the heat generated by the iron oxide particles in an alternating electromagnetic field.
This problem is solved according to the invention by a preparation comprising the characteristics described in claim 1. The subclaims and the subsequent description of an embodiment disclose other characteristics and advantageous improvements of the invention.
The invention is based on the concept of using a suspension of nanoscalar particles designed based on the description given in DE 197 26 282 for treating rheumatic joint diseases, said particles comprising, in a first embodiment, a core containing iron oxide, an inner shell that encompasses said core and comprises groups capable of forming cationic groups, and an outer shell made of species comprising neutral and/or anionic groups, and radionuclides and cytotoxic substances bound to said inner shell. These nanoscalar particles may also be one-shelled, i.e. consist just of the core and the inner shell, designed as described above.
It has been found that despite the fact that phagocytic activity in the synovial fluid decreases as the patients"" age increases, intracellular adsorption of the particles according to the invention in macrophages is increased even in pathologically changed macrophage titers in the joint cavity, and that the inflammatory process is controlled as said particles adhere to actively proliferating cells of the synovia. Due to these effects and the heat generated when applying an alternating electromagnetic field, the radionuclides show increased efficacy as compared to radiosynoviorthesis. Last but not least, success of treatment is increased beyond the additive effect of each component due to binding substances that have a cytotoxic effect when exposed to heat to the particles, as this efficiently combines radiotherapy, thermotherapy, and chemotherapy.
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